Skip to content

Baha 92132Recalls & reported problems

Cochlear Bone Anchored Solutions AB · BA210 abutment 5.5mm for flange fixture · Class 2 · Implant

Adverse event reports
9
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09321502018951), received between Nov 13, 2017 and Mar 30, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available6
  • Patient Device Interaction Problem3

Patient problems

  • Skin Infection3
  • Impaired Healing2
  • No Clinical Signs, Symptoms or Conditions2
  • Host-Tissue Reaction1
  • Skin Irritation1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE AND WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER MAC ANESTHESIA ON (B)(6) 2025, AND A NEW ABUTMENT WAS REPLACED.

    Patient problems: Skin Infection

    MAUDE report 21728460 ↗
  • InjuryMay 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Patient problems: Skin Infection

    MAUDE report 17028612 ↗
  • InjuryMay 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Patient problems: Skin Infection

    MAUDE report 17028611 ↗
  • InjuryMay 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6) 2022, IN ORDER TO RE-ATTACH THE ABUTMET.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14483393 ↗
  • InjuryMay 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY ON (B)(6) 2022, IN ORDER TO RE-ATTACH THE ABUTMET.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14483177 ↗
  • InjuryJun 16, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AT THE ABUTMENT SITE AND SUBSEQUENTLY, UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2021 IN ORDER TO REMOVE THE EXCESS SKIN.

    Patient problems: Impaired Healing

    MAUDE report 12007032 ↗
  • InjuryJun 16, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AT THE ABUTMENT SITE AND SUBSEQUENTLY, UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2021 IN ORDER TO REMOVE THE EXCESS SKIN.

    Patient problems: Impaired Healing

    MAUDE report 12007029 ↗
  • InjuryDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER THE CLINIC, THE PATIENT DEVELOPED SKIN IRRITATION WITH RE-OCCURRING DISCHARGE AND SKIN BREAKDOWN AT THE IMPLANT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH SILVER NITRATE CREAM LOCALLY, AND A COURSE OF ORAL ANTIBIOTICS (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS INSITU. THE PATIENT WILL CONTINUE TO BE ROUTINELY MANAGED BY THEIR HEALTHCARE PROVIDER.

    Patient problems: Skin Irritation

    MAUDE report 7119259 ↗
  • InjuryNov 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA FOR A SURGICAL PROCEDURE ON (B)(6) 2017, AND EXCESS SKIN WAS EXCISED AND A LONGER ABUTMENT WAS PLACED ON THE FIXTURE.

    Patient problems: Host-Tissue Reaction

    MAUDE report 7027098 ↗

Other Hearing aid, bone conduction devices

All Hearing aid, bone conduction devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.